* Drug treats lung infection common in cystic fibrosis
* Inhaled version of older Novartis drug Tobi
WASHINGTON, Sept 5 U.S. drug advisers on
Wednesday backed a new form of Novartis AG's inhaled
antibiotic that treats a lung infection linked to cystic
A panel of outside advisers to the U.S. Food and Drug
Administration voted 13 to 1 that Novartis had demonstrated that
its tobramycin inhalation powder, or TIP, was safe and
effective. The FDA usually follows panel recommendations,
although it is not required to do so, and will make a final
Novartis is seeking approval of the antibiotic powder, which
patients can take with an inhaler, as a more convenient
alternative to its older version of tobramycin called Tobi that
required use of a nebulizer machine.
"I think it's wonderful there's an additional drug
available. Its importance, as with any new drug, will be
determined over time," said panel member Dr. Paul Auwaerter,
clinical director in infectious diseases at the Johns Hopkins
School of Medicine.
TIP treats a lung infection that often afflicts patients
with cystic fibrosis, a genetic disease that affects about
30,000 people in the United States.
Ahead of the panel meeting, clinical reviewers from the FDA
had questioned whether the data showed TIP truly helped cystic
fibrosis patients breathe better, especially compared to the
company's older Tobi drug.
But most panel members on Wednesday said the company had
sufficiently proven TIP was just as safe and effective.
"As is often the case, the available data are imperfect,"
said panel member Dr. Melvin Weinstein, chief of the division of
infectious diseases at the Robert Wood Johnson Medical School in
New Jersey. "But that said, the efficacy appears to be similar
to Tobi, and I don't see enough of a (safety) signal to prevent
approval of this drug."
The tobramycin powder, administered with an inhaler, has
already been approved for use in Europe and Canada. Overall
sales of the "Tobi" inhaled antibiotic - which includes the
inhaled powder and the nebulized solution - were $296 million in
2011, Novartis said.
Cystic fibrosis causes the thin layer of mucus that helps
keep lungs free of germs to thicken, clogging airways and
damaging the lungs. The average life expectancy for the disease
is 37 years as damage to the lungs progresses and limits the
ability to breathe.
The thickening of mucus results in life-threatening
infections that must be treated with antibiotics. Novartis's
drug treats an infection called pseudomonas aeruginosa.
Earlier on Wednesday, Novartis shares closed up 1.3 percent
at 56.65 francs in trading on the Swiss stock exchange.